Prospective Cohort Study on the Safety and Efficacy of Endorobotics for Endoscopic Submucosal Dissection (Endorobotics ESD)

The Chinese University of Hong Kong

Status: Not yet enrolling

Conditions: Gastrointestinal Neoplasm

Treatments: Procedure: Endoscopic submucosal dissection with EndoRobotics traction device

Study type: Interventional

Funder types: Other

Identifiers

NCT06726798

CUHK EndoRobotics

Details and patient eligibility

About

This trial is a prospective, single arm study of 30 patients recruited to undergo endoscopic submucosal dissection (ESD) with a novel robotic assisted technology. It will assess the safety and performance of robotic-assisted endoscopic submucosal dissection (ESD) of superficial gastric and colorectal lesions that otherwise cannot be optimally and radically removed by snare-based techniques. The primary outcome of the study is rate of complete (R0) resection of the neoplasia.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with endoscopic diagnosis of early gastric or colorectal neoplasia
• Patients will be recruited according to ESGE and JGES guidelines for gastric & colorectal ESD including: 1. Lesions for which en bloc resection with snare EMR is difficult to apply; 2. Mucosal tumors with submucosal fibrosis; 3. Sporadic tumors in conditions of chronic inflammation and 4. Local residual or recurrent early carcinomas after endoscopic resection.

Exclusion criteria

• Informed consent not available
• Carcinoma of colon or rectum or stomach with invasion to submucosa or beyond
• Evidence of distant metastasis
• Presence of another active malignancy
• Pregnancy
• Patients unfit for general anesthesia
• Endoscopic platform cannot reach target lesion
• Patients recruited into another clinical trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Robotic ESD arm

Experimental group

Treatment:

Procedure: Endoscopic submucosal dissection with EndoRobotics traction device